Combination Products Regulation, Policy & Best Practices
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9:00 a.m. – 9:15 a.m. |
Welcoming Remarks Quynh Hoang, Consultant, King & Spalding LLP |
9:15 a.m. – 9:45 a.m. |
Keynote Address: Combination Products — Perspective of the Combination Products Coalition Bradley Merrill Thompson, Member, Epstein Becker & Green P.C. |
9:45 a.m. – 11:00 a.m. |
Panelists: Kirsten Paulson, Senior Director, Global CMC-Medical Device, Pfizer Moderator: David Fox, Partner, Hogan Lovells |
11:15 a.m. – 12:15 p.m. |
Postmarket Adverse Event Reporting and cGMP: What You Absolutely Need to Know Panelists: Khaudeja Bano, MD, Senior Medical Director, Abbott Moderator: Steve Niedelman, Lead Quality Systems and Compliance Consultant, King & Spalding LLP |
1:15 p.m. – 2:15 p.m. |
Promotion and Advertising of Combination Products: Key Postmarket Considerations Panelists: Glenn Byrd, Senior Director, Promotional Regulatory Affairs, AstraZeneca Moderator: Lisa Dwyer, Partner, King & Spalding, LLP |
2:15 p.m. – 3:15 p.m. |
Panelists: Tor Alden, President, HS Design Moderator: David Fox, Partner, Hogan Lovells |
3:30 p.m. – 4:30 p.m. |
Panelists: Elaine Tseng, Partner, King & Spalding LLP Moderator: Quynh Hoang, Senior Regulatory Consultant, King & Spalding LLP |